SFDA Drugs Dataset Analysis

SFDA Drugs

Summary

This documents provide general description SFDA drugs with comparing between Saudi drugs and non-Saudi drugs such as comparing prices, drug type, route of administration. shiny app is also available which provide interactive searchable table, interactive map, plot for SFDA drugs and paracetamol calculator.

Introduction

The Saudi Food and Drug Authority (SFDA) was established under the Council of Ministers resolution as an independent body corporate that directly reports to The President of Council of Ministers. The Authority objective is to ensure safety of food and drug for human and animal, and safety of biological and chemical substance as well as electronic products.

The main purpose of the SFDA establishment is to regulate, oversee, and control food, drug, medical devices, as well as to set mandatory standard specifications thereof, whether they are imported or locally manufactured. The control and/or testing activities can be conducted in the SFDA or other agency’s laboratories.

Moreover, the SFDA is in charge of consumers awareness on all matters related to food, drug and medical devices and all other products and supplies. it is consumer responsibility to ensure unregistered drugs/products is tested against safety and efficacy

Data description

human drug dataset will be used and analyzed, it is available in SFDA website.

Summary of variables in the dataset:

Variable Description
Register Number Every drug has unique registered number
Register Year Year of drug registration
Product type All drugs for human use
Drug Type Generic, biological, NCE (new chemical entity), Radio pharmaceutical or Health products
Sub-Type Allergen product, biological bio, biosimilar, Biotechnology product ..etc
Scientific Name Generic Name
Scientific Name Arabic Generic name in Arabic
Trade Name Commercial name
Trade Name Arabic Commercial name in Arabic
Strength Strength of active ingredients in the drug
Strength Unit Strength Unit such as mg, g , ml …etc
Pharmaceutical Form solution, powder for inj..etc
Administration Route Route of Administration
AtcCode1 Anatomical Therapeutic Chemical (ATC) Classification, main pharmacological group
AtcCode2 Pharmacological or Therapeutic subgroup
Size drug size
Size Unit unit size such as ml
Package Types Blister, Bottle, Vial, Ampule ..etc
Package Size size of the package
Legal Status prescription or Over counter drug
Product Control controlled/uncontrolled
Distribute area hospital or pharmacy
Public price public price for the drug in SR
shelf Life length of time that a drug can be stored in months
Storage conditions specific requirements for registered drugs
Marketing Company a company that provides marketing services for drugs
Marketing Country a country that provides marketing services for drugs
Manufacture Name Manufacture Name of drugs
Manufacture Country Manufacture Country of the drugs
2Manufacture Name second Manufacture Name of drugs
Manufacture Country Country of the drug manufacturer
Secondary package manufacture
Main Agent company that provides organizing transactions between two other parties.
Second Agent there could be more than 1 agent for the same drug
Third agent there could be more than 2 agents for the same drug
Marketing Status all drugs are marketed
Authorization Status valid or suspended

Data Comparison

ggplot(HumanDrugs) +
    geom_bar(aes(x = Drug_Status, fill = Drug_Status), 
             position = "dodge", stat = "count")+
  theme_classic()+
    scale_y_continuous("Number of Drugs", limits = c(0,7000), expand = c(0,0))+

scale_fill_manual(values=c("#BE3144", "#113A5D"))

HumanDrugs %>% 
    group_by( Drug_Status ) %>% 
    summarise( percent = 100 * n() / nrow( HumanDrugs ) )
## # A tibble: 2 x 2
##   Drug_Status     percent
##   <chr>             <dbl>
## 1 Non Saudi Drugs    69.7
## 2 Saudi Drugs        30.3

overall, Saudi drugs contributes to only 30% of registered drugs

by ATCcode, keeping unique value

RegisterYear

Year of drug registration

ggplot(HumanDrugs) +
    geom_bar(aes(x = RegisterYear, fill = `Legal Status`), 
             position = "dodge", stat = "count")+
  facet_grid(~Drug_Status)+
  theme_minimal()+
scale_fill_manual(values=c("#BE3144", "#113A5D"))

Starting of Saudi company was almost after 90s, the peak in recent years, the presences of covid-19 might affect increasing drug registration especially for non-Saudi drugs.

Public Price



HumanDrugs %>% select(`Public price`) %>% summary()
#ggplot(HumanDrugs) +
   # geom_bar(aes(x = `Public price`, fill = as.factor(`Legal Status`)), 
         #    position = "dodge", stat = "count")
HumanDrugs  %>% filter(`Public price`< 1000,`Distribute area`!="NA" ) %>% 
  ggplot( aes(x = RegisterYear, y = `Public price`, color=`Distribute area`)) + 
 geom_jitter(alpha = 0.7)+
  # geom_ribbon(alpha = 0.3)+
  scale_x_continuous("Register Year", limits = c(1980,2021), expand = c(0,0))+
  facet_grid(~Drug_Status)+
      theme_minimal()+
scale_color_manual(values=c("#BE3144", "#113A5D"))
## Warning: Removed 210 rows containing missing values (geom_point).

in general, higher prices in recent years for hospital distribution,

pleas note that there are 230 missing values in the plot which cover 3% of the data this issue has been solved in the shiny app, which provide scalable price index with ability to navigate the drug for each country.

HumanDrugs  %>% filter(`Public price`< 150,`Distribute area`!="NA" ) %>% 
  ggplot( aes(x  = `Public price`)) + 
  geom_histogram(binwidth = 3, center=5, fill="#113A5D")+
  facet_grid(~Drug_Status)+
  theme_minimal()+
scale_x_continuous("Price", limits = c(1,150), expand = c(0,0))
## Warning: Removed 19 rows containing non-finite values (stat_bin).
## Warning: Removed 4 rows containing missing values (geom_bar).

  #scale_x_continuous("Register Year", limits = c(1980,2021), ex5

more cheaper medications is synthesized

DrugType

almost 2/3 of drugs are generic followed by A New Chemical Entity drugs.

DrugType n
Generic 4735
NCE 2263
Biological 620
Radiopharmaceutical 6
Health 4
 HumanDrugs  %>% filter(DrugType != "NA") %>% 
  #arrange(desc(DrugType))
ggplot( aes(x = DrugType, fill = Drug_Status)) + 
  geom_bar(position = "dodge")+
  theme_minimal()+
scale_fill_manual(values=c("#BE3144", "#113A5D"))

most common drugs are Generic or NCE, It makes a sense because biological and radiophamaceticals are since these drugs used in serious diseases such as cancer! description of each type

1- A generic drug is a medication that has exactly the same active ingredient as the brand name drug and yields the same therapeutic effect.(1)

2- A New Chemical Entity (NCE) is a drug that does not contain any active moiety that has been approved by FDA with any other application. The manufacturers of an innovator drug generally develop a NCE during the early development stage of the product cycle. The NCE, then, undergoes various clinical trials in order to transform into a drug product(2).

3- Biological drugs (commonly referred to as ‘biologics’ or ‘biopharmaceuticals’) are drugs produced through biological processes. They currently target diseases which, hitherto, had very limited or no available treatment options – including several types of cancers, autoim- mune diseases and other non-communicable diseases(3).

4- Radiopharmaceuticals are radioactive chemicals or pharmaceutic preparations, labeled with a radionuclide in tracer or therapeutic concentration (4).

Comparing Drug type against price

ADMINSTRATION ROUTE

 HumanDrugs%>% filter(AdministrationRoute %in%  ROA10) %>% 
  
ggplot( aes(x = AdministrationRoute, fill = Drug_Status)) + 
  geom_bar(position = position_dodge(width = 0.2)) +
 scale_fill_brewer(palette = "Paired")+
theme_minimal()

finding our focus

Saudi manufacturer focus more on oral drugs followed by Iv drugs but then what kind of iv drug provided?

sdrugs%>% filter ( AdministrationRoute =="Intravenous") %>% group_by (`Scientific Name`) %>% 
  summarise(`Trade Name` = n()) %>% arrange(desc(`Trade Name`))%>% 
  head(10)%>% knitr::kable()
Scientific Name Trade Name
DEXTROSE, SODIUM CHLORIDE 62
DEXTROSE 58
SODIUM CHLORIDE 21
WATER 17
SODIUM BICARBONATE 12
MAGNESIUM CHLORIDE6H2O , POTASSIUM CHLORIDE , ACETIC ACID , CALCIUM CHLORIDE 2H2O , DEXTROSE MONOHYDRATE , SODIUM CHLORIDE 9
BALANCED ELECTROLYTES 8
MAGNESIUM CHLORIDE6H2O , Potassium chloride , ACETIC ACID , Calcium chloride 2H2O , DEXTROSE MONOHYDRATE , Sodium chloride 8
POTASSIUM CHLORIDE, SODIUM CHLORIDE 8
POTASSIUM CHLORIDE 7

ok, thats what I expect, manufacturer focus really on basic treatment which is may not be spesifc to any disease we have also import top 3 from other countries. let us try on oral medications

sdrugs%>% filter ( AdministrationRoute =="Oral") %>% group_by (`Scientific Name`) %>% 
  summarise(`Trade Name` = n()) %>% arrange(desc(`Trade Name`))%>% head(10) %>% knitr::kable()
Scientific Name Trade Name
PREGABALIN 41
MONTELUKAST SODIUM 26
TADALAFIL 24
LEVETIRACETAM 23
OLANZAPINE 21
QUETIAPINE FUMARATE 21
AZITHROMYCIN 20
SILDENAFIL CITRATE 20
ETORICOXIB 19
GLIMEPIRIDE 18

This is gives us better idea than IV drugs pregablin in the top Pregablin in last 5 years this drug has been added to controlled drugs beacuse they found that it cause addiction. Many patients still addict to this medication. so it is consumer need! MONTELUKAST used as prophylaxis and chronic treatment of asthma and Allergic or Perennial Rhinitis which is expected because of our dusty weather Tadalfil & SILDENAFIL used in pulmonary hypertension and impotence Levetiracetam is anti-epliptic OLANZAPINE $ QUETIAPINE FUMARATE is anti-psychiatric medications. they can be overuse Glimepiride, finally we got is an anti-diabetic medication! Honestly, I was expected antidiapetic & antihypertensive medication to be in the top.

HumanDrugs$`Scientific Name` = tolower(HumanDrugs$`Scientific Name`)


HumanDrugs %>% distinct(`Scientific Name`)->dis_Human_drugs

Finding oral exclusive:

sdrugs%>% filter ( AdministrationRoute =="Oral") %>% select (AtcCode1,`Scientific Name`,`Drug_Status`) ->oral_SATC

nosdrugs%>% filter ( AdministrationRoute =="Oral") %>% select (AtcCode1,`Scientific Name`,`Drug_Status`) ->oral_No_SATC

oral_SATC %>% 
  anti_join(oral_No_SATC, by = "Scientific Name") ->anti_for_oralsat
anti_for_oralsat %>% distinct(`Scientific Name`)-> d_anti_for_oralsat
sdrugs%>% filter ( AdministrationRoute =="Intramuscular") %>% group_by (`Scientific Name`) %>% 
  summarise(`Trade Name` = n()) %>% arrange(desc(`Trade Name`))%>% 
  head(10)%>% 
  
  knitr::kable()
Scientific Name Trade Name
CEFTRIAXONE 4
CEFAZOLIN 2
CEFEPIME HYDROCHLORIDE 1
CEFOTAXIME 1
CHORIONIC GONADOTROPHIN (HCG) 1
DIPHTHERIA, HEMOPHILUS INFLUENZAE B, PERTUSSIS, TETANUS, HEPATITIS B 1
KETOPROFEN 1
PIROXICAM 1
VITAMIN B6 (PYRIDOXINE HYDROCHLORIDE) , VITAMIN B1 (THIAMINE HYDROCHLORIDE) , VITAMIN B12 (CYANOCOBALAMIN) 1
sdrugs%>% filter ( AdministrationRoute =="Intravenous") %>% group_by (`Scientific Name`) %>% 
  summarise(`Trade Name` = n()) %>% arrange(desc(`Trade Name`))%>% 
  head(10)%>% knitr::kable()
Scientific Name Trade Name
DEXTROSE, SODIUM CHLORIDE 62
DEXTROSE 58
SODIUM CHLORIDE 21
WATER 17
SODIUM BICARBONATE 12
MAGNESIUM CHLORIDE6H2O , POTASSIUM CHLORIDE , ACETIC ACID , CALCIUM CHLORIDE 2H2O , DEXTROSE MONOHYDRATE , SODIUM CHLORIDE 9
BALANCED ELECTROLYTES 8
MAGNESIUM CHLORIDE6H2O , Potassium chloride , ACETIC ACID , Calcium chloride 2H2O , DEXTROSE MONOHYDRATE , Sodium chloride 8
POTASSIUM CHLORIDE, SODIUM CHLORIDE 8
POTASSIUM CHLORIDE 7

Manufacturer Country

top 10 Manufacturer Countries

HumanDrugs %>% count(`Manufacture Country`, sort=T) %>% head(10)
## # A tibble: 10 x 2
##    `Manufacture Country`     n
##    <chr>                 <int>
##  1 Saudi Arabia           2315
##  2 Jordan                  629
##  3 Germany                 562
##  4 United States           452
##  5 United Arab Emirates    319
##  6 United Kingdom          317
##  7 France                  290
##  8 Italy                   287
##  9 India                   268
## 10 Switzerland             238
#%>% 
#ggplot(aes(x = `Manufacture Country`)) +
           # geom_bar(  position = "dodge", stat = "count")

Shelf life

length of time that a drug can be stored in months. It differ than expiration date. From medical perspective: The shelf life generally relates to a drug’s quality over a specified period of time, whereas the expiration date relates to both quality and safety of a medication at a specific point in time(5).

  ggplot(HumanDrugs, aes(x =shelfLife)) +
    geom_density() +
   scale_x_continuous("Shelf Life", limits = c(10,80), expand = c(0,0))
## Warning: Removed 10 rows containing non-finite values (stat_density).

as it shown, most of medicatins shelf life between 20 to 40 months which is almost equal to 2-3 years price vs shelf life

General Information

Top 10 Highly consumed Drugs

many trade drugs for same generic drugs means that is highly consumed

HumanDrugs%>% group_by (`Scientific Name`) %>%
  summarise(`Trade Name` = n()) %>% arrange(desc(`Trade Name`))%>% head(10) %>% knitr::kable()
Scientific Name Trade Name
sodium chloride 111
dextrose, sodium chloride 81
dextrose 78
diclofenac sodium 63
amoxicillin, clavulanic acid 62
paracetamol 62
quetiapine fumarate 61
ciprofloxacin 55
montelukast sodium 54
tadalafil 54

Sodium Chloride Normal saline, it is widely used in the hospitals which make a sense that is the most common one

DExtrose Also widly used, it is simple sugar, so mainly used for Hypoglycemia, it is used along with Sodium clorde

Paracetamol & diclofinac both are pain killers, both are widely used inside and outside hospitals, both have oral form, In general, Diclofinac is available also as intermuscular which make it prefered mild to moderate pain killer in the ER rather than parecetamol (IV) which may take longer time.

amoxicillins&clavunic acid β-lactam antibiotics (beta-lactam antibiotics), it has wide antibactrial spectrum covering & it taken orally, generally it can treat: : Ear, Nose, & Throat Infections,Genitourinary Tract Infections,Skin & Skin Structure Infections,Lower Respiratory Tract Infections

QUETIAPINE it is used for psychiatric disorders such as: Major Depressive Disorder, Schizophrenia,Bipolar I Disorder & insomnia

CIPROFLOXACIN Fluoroquinolones antibiotics, unlike amoxicillin which is available only in oral dose, cipro also has IV form which make it suitable for inpatients hospitals, it covers lower respiratory tract infections such as Pneumonia, urinary tract infections (UTI), bone & skin infection.

MONTELUKAST SODIUM it is used as prophylaxis and chronic treatment of asthma and Allergic or Perennial Rhinitis

Pregabalin Antiepileptic Agent Useful for Neuropathic Pain, it has also anticonvulsant, analgesic, and anxiolytic properties. in last 5 years this drug has been added to controlled drugs beacuse they found that it cause addiction.Many patients still addict to this medication. so it is consumer need!

What are the top 10 registered priced drugs?

HumanDrugs %>% select(`Public price`,`Scientific Name`,`DrugType`,`RegisterYear`,`Manufacture Country`,`AdministrationRoute`) %>% arrange(desc(`Public price`)) %>% head(10)  %>% knitr::kable()
Public price Scientific Name DrugType RegisterYear Manufacture Country AdministrationRoute
1759274.32 voretigene neparvovec Biological 2020 United Kingdom NA
1633500.00 tisagenlecleucel Biological 2020 United States Intravenous
394762.50 nusinersen NCE 2019 Italy INTRATHECAL
95189.65 eliglustat NCE 2018 Ireland Oral
83063.45 catridecacog NCE 2015 Denmark Intravenous
77094.89 larotrectinib NCE 2020 United Kingdom Oral
72568.25 grazoprevir, elbasvir NCE 2016 Ireland Oral
65083.35 ipilimumab Biological 2015 United States Intravenous
56854.95 erdafitinib NCE 2021 Italy Oral
52774.45 lanadelumab Biological 2020 United States Subcutaneous

Voretigene Neparvovec is an adeno-associated viral gene therapy used to treat biallelic RPE65 mutation associated retinal dystrophy it is subretinal injection. FDA aprroved in 2017

Tisagenlecleucelsold under the brand name Kymriah, is a medication for the treatment of B-cell acute lymphoblastic leukemia (ALL) which uses the body’s own T cells to fight cancer (adoptive cell transfer).Acute lymphoblastic leukemia in children is more common than other types of cancer

NUSINERSEN used in treating spinal muscular atrophy (SMA), a rare neuromuscular disorder.In December 2016, it became the first approved drug used in treating this disorder.

ELIGLUSTAT used for the long-term treatment of Gaucher disease type 1

CATRIDECACOG indicated in patients with a rare clotting disorder, congenital factor XIII A-subunit deficiency, which is a kind of Factor XIII deficiency. The drug prevents bleeding in patients with this condition, and has been approved FDA in 2014.

LAROTRECTINIB is for adults and children with solid tumors that test positive for NTRK genes, which can help cancerous tumors grow. Tumors with this type of genetic change are not common but can be found in cancers of the salivary gland, thyroid, lung, and soft tissue sarcoma

GRAZOPREVIR Antiviral drug for choroinc heptits c infection, hepatitis C protease inhibitor.

IPILIMUMAB

ERDAFITINIB

Lanadelumab

Top priced drug for each manufucure contry registered in SFDA

####
# Make a color palette called pal for the values of `Distribution area` using `colorFactor()`  
pal <- colorFactor(palette = c("#A9333A", "#000D6B"), 
                   levels = c("Hospital", "Pharmacy"))

# Add circle markers that color colleges using pal() and the values of sector_label

leaflet(top_price) %>% 
  addProviderTiles(provider = "CartoDB") %>% 
  addCircles(lng = ~longitude, lat = ~latitude) %>% 
  clearBounds() %>% 
  clearMarkers()%>%
  
 # addMarkers(data = top_price) %>%
  #my_Map %>%

  addCircleMarkers(data = top_price, radius = 5, 
                   color = ~pal(`Distribute area`), 
                   label = ~paste0(`Trade Name`,"(price=",`Public price`,"SR)" )) %>% 
  addLegend(position="bottomright", pal = pal,title = "Distribution area " ,
            values = c("Hospital", "Pharmacy"))
## Assuming "longitude" and "latitude" are longitude and latitude, respectively

what are suspended drugs

 HumanDrugs %>% filter (`Authorization Status`=="Suspended")%>% select(`Scientific Name`, `Manufacture Country`,RegisterYear,`Legal Status`) %>% knitr::kable()
Scientific Name Manufacture Country RegisterYear Legal Status
omeprazole Belgium 2009 Prescription
glimepiride United Arab Emirates 2012 Prescription
glimepiride United Arab Emirates 2011 Prescription
glimepiride United Arab Emirates 2011 Prescription
metformin hydrochloride United Arab Emirates 2009 Prescription
clarithromycin United Arab Emirates 2002 Prescription
simethicone (activated dimethicone) Switzerland 2015 OTC
venlafaxine hydrochloride Saudi Arabia 2018 Prescription
venlafaxine hydrochloride Saudi Arabia 2018 Prescription
pantoprazole sodium sesquihydrate Egypt 2017 Prescription
pregabalin Saudi Arabia 2017 Prescription
pregabalin Saudi Arabia 2017 Prescription
esomeprazole magnesium Saudi Arabia 2019 Prescription
esomeprazole magnesium Saudi Arabia 2019 Prescription
esomeprazole magnesium Saudi Arabia 2019 Prescription
esomeprazole magnesium Saudi Arabia 2019 Prescription

Conclusion

Although Saudi pharmaceutical companies started in late 90s, but it seems we are very dependents on international pharmaceutical companies. the focus on intravenous medication was on sodium Chloride and other electrolytes, while on oral medication was on pain killers and antidepressants, there are opportunities for Saudi pharmaceutical companies to focus on syntheses of other medications that are used to treat chronic disease as we have emerging of serious diseases such as IHDD and stroke which is the main cause of mortality in Saudi Arabia 67.

library(plotly)
## 
## Attaching package: 'plotly'
## The following object is masked from 'package:ggplot2':
## 
##     last_plot
## The following object is masked from 'package:stats':
## 
##     filter
## The following object is masked from 'package:graphics':
## 
##     layout
fig <- plot_ly(iris, x = ~Petal.Length, y = ~Petal.Width, type = 'scatter', mode = 'markers',
        hoverinfo = 'text',
        text = ~paste('</br> Species: ', Species,
                      '</br> Petal Length: ', Petal.Length,
                      '</br> Petal Width: ', Petal.Width))



fig <- plot_ly(HumanDrugs, x = ~RegisterYear, y = ~`Public price`, type = 'scatter', mode = 'markers',
        hoverinfo = 'text',
        text = ~paste('</br> Trade Name : ', `Trade Name`,
                      '</br> Scientific Name: ', `Scientific Name`,
                      '</br> Public price: ', `Public price`))
fig
## Warning: Ignoring 3 observations

References

(1)Sfda.gov.sa. 2021. Overview | Saudi Food and Drug Authority. [online] Available at: https://www.sfda.gov.sa/en/overview [Accessed 13 November 2021].

()Institute for Health Metrics and Evaluation. 2021. Saudi Arabia. [online] Available at: http://www.healthdata.org/saudi-arabia [Accessed 13 November 2021].

()World Life Expectancy. 2021. HEALTH PROFILE SAUDI ARABIA. [online] Available at: https://www.worldlifeexpectancy.com/country-health-profile/saudi-arabia [Accessed 13 November 2021].